Laryngeal Mask Supreme™ Versus the I-gel™
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00653237 |
Recruitment Status :
Completed
First Posted : April 4, 2008
Last Update Posted : March 12, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Patients Undergoing Elective General Anesthesia | Device: I-gel and LMA Supreme: supraglottic airway devices | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 60 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | A Comparison of The Laryngeal Mask Supreme™ and the I-gel™ in a Simulated Difficult Airway Scenario in Anesthetized and Ventilated Patients |
Study Start Date : | March 2008 |
Actual Primary Completion Date : | July 2008 |
Actual Study Completion Date : | July 2008 |
Arm | Intervention/treatment |
---|---|
1
crossover trial. insertion of both devices consecutively, computer randomized order
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Device: I-gel and LMA Supreme: supraglottic airway devices
Insertion of a supraglottic airway device
Other Name: Laryngeal Mask Supreme, supraglottic airway device |
- first attempt success rate and time to success [ Time Frame: during intervention ]
- leak pressure [ Time Frame: during intervention ]

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- ASA 1-3 patients undergoing elective operation
Exclusion Criteria:
- Not speaking german or refusing to participate
- BMI >35, <50kg
- Planned operation time >4h
- High risk of aspiration
- Cervical spine disease, known difficult airway, mouth opening <20mm
- Upper respiratory tract symptoms in the previous 10 days
- Preoperative sore throat
- Poor dentition with high risk of damage

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00653237
Switzerland | |
University Hospital | |
Berne, Switzerland, CH-3010 |
Study Director: | Robert Greif, M.D. | Department of Anesthesia, University Hospital Berne, Switzerland |
Responsible Party: | University Hospital Inselspital, Berne |
ClinicalTrials.gov Identifier: | NCT00653237 |
Other Study ID Numbers: |
igellma-1 |
First Posted: | April 4, 2008 Key Record Dates |
Last Update Posted: | March 12, 2014 |
Last Verified: | March 2014 |
Chlorhexidine Anti-Infective Agents, Local Anti-Infective Agents Disinfectants |